Hypromellose Phthalate

Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 29-Apr-2022
Official Date: 01-May-2023
Expert Committee: Complex Excipients
Coordinating Pharmacopeia: European Pharmacopeia

A revision to the harmonized standard for Hypromellose Phthalate has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Having reached Stage 4 of the PDG process, the Hypromellose Phthalate monograph has been formally approved by the USP Complex Excipients Expert Committee in accordance with the Rules and Procedures of the 2020–2025 Council of Experts.

Changes from the existing USP–NF monograph include:

  •  Limit of Free Phthalic Acid
    • Specified five (5) replicate injections for system suitability – relative standard deviation (RSD) determination.
  • Additionally, minor editorial changes have been made to update the monograph to current USP style.

The Hypromellose Phthalate monograph will be incorporated into and become official with the USP-NF 2023 (May 1, 2023).

Should you have any questions about the Hypromellose Phthalate monograph, please contact Dr. Tong (Jenny) Liu (240-221-2072 or jyl@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or rll@usp.org).

The previous PDG sign-offs and Stage 4 postings are included as below: